Kornimate/medical-research-clean huggingface dataset:
antiviral therapy in infants with hbv infection

Conditions: HBV

Summary: this study was a multicenter, prospective randomized controlled clinical study. a total of 60 hbv-infected infants with alt ≤5 times the upper limit of normal (uln) and without pathological jaundice were enrolled and randomized 1:1 into two groups: the control group and the antiviral treatment group. hbv-infected infants in the treatment group were treated with lam before the age of 1 year and then combined with regular interferon for 52 weeks if they were still positive for hbv dna and/or hbsag after reaching the age of 1 year. the control group was followed up synchronously. follow-up was conducted every 3 months during the study period. the main efficacy evaluation indexes: hbsag conversion (functional cure) rate, hbeag conversion rate, hbeag seroconversion rate, hbv dna conversion rate, hbsag seroconversion rate, and alt reversion rate at the end of 12 months of treatment and at 2 years of age.


Eligibility criteria:
inclusion criteria: * a. age ≤ 1 year; * b. hbsag and hbv dna positive; * c. alt ≤ 5 times the upper limit of normal (uln) and no pathologic jaundice (two consecutive tests with an interval of 2 weeks - 3 months). * d. parents are willing to participate in the study and sign an informed consent form, for children without parents, all legal guardians of need to give informed consent. exclusion criteria: * a. combined viral infections such as hav, hcv, hdv, hev, hiv, ebv, cmv, etc; * b. combination of other liver diseases, such as autoimmune hepatitis, drug-induced liver injury, wilson's disease; * c. wbc \<9 × 10\^9/l, or plt \<90 × 10\^9/l; * d. combination of other systemic serious diseases or hereditary diseases, etc; * e. other conditions deemed by the investigator to be unsuitable for participation in this study.
gemcitabine/irinotecan/zd1839 vs paclitaxel/carboplatin/etoposide/zd1839 in carcinoma of unknown primary site

Conditions: Neoplasms, Unknown Primary

Summary: in this randomized trial, we will investigate the activity and toxicity of two active regimens, gemcitabine/irinotecan and paclitaxel/carboplatin/etoposide (both followed by zd1839) in the first-line treatment of patients with carcinoma of unknown primary site.

upon determination of eligibility, all patients will be randomly assigned to one of two treatment arms: * paclitaxel + carboplatin + etoposide * irinotecan + gemcitabine patients will be stratified by tumor location (liver/bone versus all others) and number of metastatic sites (one versus two or more). patients with an objective response or stable disease after completion of chemotherapy will receive zd1839 until disease progression. patients who do not respond to chemotherapy may crossover to the other chemotherapy regimen and will receive zd1839 if they have an objective response or stable disease. the study is not blinded so both the patient and the doctor will know which treatment has been assigned.

Eligibility criteria:
inclusion criteria: to be included in this study, you must meet the following criteria: * carcinoma of unknown primary site * biopsy-proven metastatic carcinoma * able to perform activities of daily living with minimal assistance * no previous treatment with any systemic therapy * measurable or evaluable disease * adequate bone marrow, liver and kidney function * understand the nature of this study and give written informed consent exclusion criteria: you cannot participate in this study if any of the following apply to you: * age \< 18 years * uncontrolled brain metastases and meningeal involvement * other uncontrolled malignancies * women pregnant or lactating * recent history of significant cardiovascular disease * severe or uncontrolled systemic disease * other significant clinical disorder * clinically active interstitial lung disease please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Keywords: neoplasms, unknown primary
pilot brief communal coping intervention for adults with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the investigators plan to develop a communal coping intervention aimed at instilling a shared appraisal of diabetes and increasing patient-partner collaboration. to that end, the investigators will pilot the first randomized clinical trial of a brief communal coping intervention among couples in which one person has t12

the investigators will recruit 66 couples in which one person has type 2 diabetes. power is based on effect sizes from previous couple intervention studies and meta-analyses on primary outcomes. couples will be randomly assigned to either a communal coping intervention or an attention (diabetes education) control group. all couples will come to the laboratory or meet via zoom, complete a baseline questionnaire assessment (primary and secondary outcomes, mediators) and have a videotaped conversation about how they cope with diabetes. the intervention group will receive the communal coping intervention. couples in the intervention group will identify 5 collaborative implementation intentions, whereas controls will identify 5 individual implementation intentions. after the in-person session, couples will individually complete a daily diary at the end of the day for 14 consecutive days which focuses on daily communication, mood, and patient self-care. during the first 7 days, the intervention group will receive two text messages per day (morning focus on shared appraisal, evening focus on one of collaborative implementation intentions identified during in-person session). an in-person follow-up interview will take place 6 weeks after the initial session, during which primary outcomes, secondary outcomes, and mediators will be assessed and the videotaped conversation repeated.

Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes for one year * married or living with someone for at least one year who is willing to participate in the study as the study partner * age 18 and over * reliable access to the internet at home exclusion criteria: * non-english speakers * patient has a major chronic illness that affects daily life more than diabetes (e.g., currently --undergoing treatment for cancer) * partner does not consent to participate in study * partner has diabetes
reliability of subcutaneous echogenicity (seg) grade and subcutaneous echo-free space (sefs) grade

Conditions: Postmastectomy Lymphedema Syndrome

Summary: the aims of this study is to determine the inter- and intra-rater reliability of seg and sefs grade systems for postmastectomy lymphedema.

the clinical severity of lymphedema in an extremity is generally graded according to the international society of lymphology (isl) stage. stage 0 which refers to a latent or subclinical condition where swelling is not evident despite impaired lymph transport. it may exist months or years before overt edema occurs (stages i-iii). stage i represents an early accumulation of fluid relatively high in protein content (e.g., in comparison with "venous" edema) and subsides with limb elevation. pitting may occur. stage ii signifies that limb elevation alone rarely reduces tissue swelling and pitting is manifest. late in stage ii, the limb may or may not pit as tissue fibrosis supervenes. stage iii encompasses lymphostatic elephantiasis where pitting is absent and trophic skin changes such as acanthosis, fat deposits, and warty overgrowths develop. within each stage, severity based on volume difference can be assessed as minimal (\ 40% increase). because the isl stage mainly consists of findings achieved by physical examinations and represents the most severely affected arm, it is subjective and may not reflect the distribution and mode of progression of the disease. the characteristic skin and subcutaneous tissue changes in extremities with chronic lymphedema are caused by changes in the extracellular matrix, such as connective tissue hypertrophy, fat accumulation resulting from both fat hypertrophy and an increased number of adipocytes, and interstitial protein-rich fluid accumulation. ultrasound has been used to assess and diagnose lymphedema related changes. subcutaneous echogenicity (seg) and subcutaneous echo-free space (sefs) grade systems for postmastectomy lymphedema are developed in order to grade lymphedema objectively and to delineate the disease status more clearly. however, the reliability of seg and sefs has not been evaluated. the aims of this study is to determine the inter- and intra-rater reliability of seg and sefs grade systems for postmastectomy lymphedema. two physiatrist (one ten-year-experienced and one five-year-experienced in musculoskeletal ultrasonography) independently and alternately will assess the subjects once for each assessment. three days later after the initial examination, one of the physiatrists reassessed the patients. the inter- and intra-rater reliability will be determined using kappa.

Eligibility criteria:
inclusion criteria: 1. patients with unilateral postmastectomy lymphedema exclusion criteria: 1. bilateral lymphedema 2. the patients who had known systemic edemagenic conditions (e.g., cardiac/hepatic/renal failure, terminal cancer, on chemotherapy), and/or with cancer recurrence were excluded

Keywords: imaging assessment edema dermis postmastectomy lymphedema reliability ultrasound grade
prospective validation of the code-hf algorithm for the diagnosis of acute heart failure

Conditions: Acute Heart Failure; Diagnosis

Summary: acute heart failure is a life-threatening condition where the heart is suddenly unable to pump blood around the body. it can be challenging to diagnose because the symptoms often mimic other conditions. previous studies have showed that delays in making the correct diagnosis result in worse outcomes. we therefore developed a decision-support tool called code-hf that uses a computer algorithm to combine levels of a blood test called nt-probnp with patient factors to calculate the probability of acute heart failure for an individual. in this project, we wish to evaluate the performance of code-hf in approximately 2,000 patients attending the emergency department with suspected acute heart failure. we will store surplus material from their blood tests to measure nt-probnp and link information from their electronic health records with other routinely collected medical information in regional and national databases in order to evaluate this algorithm.


Eligibility criteria:
inclusion criteria: * patients presenting to the emergency department with acute breathlessness

Keywords: artificial intelligence
comparison of responsiveness of different pain and disability measurements in plantar fasciitis

Conditions: Plantar Fasciitis, Chronic

Summary: the aim of the present study is compare the frequently used pain and disability assessment questionnaires before and after 5 sessions of standard treatment for patients admitted to the physical medicine and rehabilitation outpatient clinic for plantar fasciitis and who were queued to receive extracorporeal shock wave therapy (eswt) treatment.

the study was designed as prospective observational research. between december 2019 and may 2020, 90 patients who were admitted to the physical therapy and rehabilitation outpatient clinic for eswt were planned to be included in the study. pre-treatment pain values of patients with 3 different examination methods (visual analog scale, numerical pain scale and heel sensitivity index), 3 different disability index foot function index, foot and ankle outcome score, the american orthopedic foot and ankle society (aofas) ankle-hindfoot score will be used. these methods will be evaluated before and after eswt treatment and the responsiveness and minimal clinically important difference of the questionnaires will be compared.

Eligibility criteria:
inclusion criteria: * patients 18 years and older * patients with chronic heel complaints for more than 1 month * patients queued for eswt exclusion criteria: * patients under the age of 18 * patients who do not want to participate in the study voluntarily * patient undergone physical therapy for the same heel in the last 6 months * patients treated for heel pain * rheumatologic diseases that cause heel pain (ankylosing spondylitis, behçet's disease) * neurological diseases (such as diabetic polyneuropathy, postpolio syndrome) * patients with malignancy * illiterate patients with speech pathology

Keywords: extracorporeal shockwave therapy minimal clinically important difference pain measurement patient reported outcome measures plantar fasciitis responsiveness
tolerability comparison of differin® cream 0.1% versus differin® lotion 0.1% in subjects with healthy skin

Conditions: Skin Manifestations

Summary: the purpose of this study is to compare the tolerability of differin® (adapalene) cream, 0.1% to differin® lotion, 0.1% in subjects with healthy skin treated once a day for three (3) weeks.


Eligibility criteria:
inclusion criteria: * males or females aged 18 years and older * subjects with healthy skin as determined by the clinical grader exclusion criteria: * subjects with a degree of skin pigmentation that interferes with the reading of skin reactions. * subjects with a condition or who are in a situation, which in the investigator's opinion may put the subject at risk, may confound study results, or may interfere with the subject's participation in the study. * subjects with known allergy to one of the components of the study drugs (refer to the package insert for differin® cream 0.1% and the investigator's brochure for differin® lotion 0.1%). * subjects who have participated in another investigational drug or device research study within 30 days of enrollment. * subjects with a washout period for topical treatment on the treated area less than 1 week for corticosteroids and/or 4 weeks for retinoids. * subjects with a washout period for systemic treatment less than 1 week for medications that may increase photosensitivity and/or 4 weeks for corticosteroids and/or 6 months for retinoids. * subjects with current sunburn, eczema, atopic dermatitis, perioral dermatitis or rosacea on the area to be treated. * subjects who foresee unprotected and intense uv exposure during the study (mountain sports, uv radiation, sunbathing, etc.)
safety and efficacy investigation of the effects of clearlift q-switched nd:yag 1064nm laser module in the treatment of facial skin wrinkles

Conditions: Facial Skin Wrinkles

Summary: alma lasers clearlift is a fractional non-ablative q-switched laser, allowing practitioners to use the benefits of a high intensity qs laser for the treatment of aged skin. alma harmony clearlift uses a fractional qs laser to achieve a deep mechanical effect beneath the epidermis via a photoacustic effect. this creates a controlled dermal wound while leaving the epidermis intact. the wound healing process stimulates growth of new collagen, skin contracture and tightening. this procedure is virtually painless with no downtime and is safe for all skin types. based on this background, we have considered an interest to design a study aimed at assessing the efficacy and safety of a treatment course with clearlift module in patients with facial skin wrinkles


Eligibility criteria:
inclusion criteria: * female subjects aged ≥ 35 and ≤ 55 years * presence of type 1-3 facial skin wrinkles, according to the glogau scale; * subjects in reasonably good general health, according to investigator's judgment; * subjects who agree to avoid tanning during the entire investigational period; * subjects who agree to avoid any other facial procedure during the entire investigational period; including but not limited to: injectables or threads, peeling of any kind, dermabrasion, facial hair removal or application of any cosmoceutical/pharmaceutical without the consent from the pi only. * subjects able to understand the full nature and the purpose of the investigation, including possible risks and side effects, able to cooperate with the investigator and to comply with the requirements of the entire investigation (ability to attend all the planned investigation visits according to the time limits included) based on investigator's judgement. * subjects willing to sign an informed consent, consent to use their photos for future scientific or marketing purposes, according to the sponsor's needs. exclusion criteria: * subjects with active infections; * subjects with history of keloid scarring or hypertrophic scar formation; * subjects with previous medical treatment of the area, or oral retinoid drug prescribed within the past six months; * subjects who have been tanning within the past 30 days; * previous surgical treatment of the area selected for the treatment with the investigational device; * subjects with any inflammatory skin condition e.g., eczema, active herpes simplex, etc. at the treatment site; * subjects with presence of tattoos at the treatment site; * subjects with skin cancer or any other cancer and/or any cancer drug therapy (such as ducabaxine, fluorouracil, methotrexate, etc.); * subjects with history of autoimmune disorder or evidence of immunosuppression; * subjects with cellulitis; * subjects with collagen vascular diseases; * subjects with thrombocytopenia; * subjects with peripheral vascular disease; * subjects with melasma; * pregnant or lactating subjects.
anatomy-based resection or margin-based resection for hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma by BCLC Stage

Summary: anatomical liver resection was widely accepted as first line curative therapy for hepatocellular carcinoma. however, number of retrospective clinical studies showed no priority of anatomical resection for hepatocellular, compared with non-anatomical resection. surgical resection margin is a essential factor that may affect tumor prognosis. it is controversial whether adequate liver resection margin is associated with improved survival outcome in patients with hepatocellular. there was few prospective clinical trial to investigate whether anatomical liver resection is superior to non-anatomical resection or liver resection with adequate margin is superior to that with inadequate margin. this prospective clinical trial aims at fix these issues.

in the anatomical liver resection group, liver segmentectomy or lobectomy is performed to insure curative resection (r0 resection). the region of liver resected is based on the anatomy or portal vein and hepatic vein. the liver pedicle of the tumor located lobe is exposed and dissected, which is principle to perform anatomical liver resection. in the non-anatomical liver resection group, the liver parenchyma transection is around 0-2 cm from the tumor margin, according to tumor size and location.

Eligibility criteria:
inclusion criteria: * patients diagnosed with hepatocellular carcinoma of bclc stage a * liver function child-pugh a * normal indocyanine green retention rate * adequate liver remnant exclusion criteria: * age less than 17 y or older than 65 y * unresectable liver cancer * intraoperative ablation * contraindication for liver resection * preoperative treatment for hepatocellular * active hepatitis * pregnant * multi-original tumors * mixed liver cancer (hepatocellular carcinoma and cholangiocellular carcinoma) * tumor recurrence

Keywords: hepatocellular carcinoma anatomical liver resection
impact of feeding on pro-inflammatory cytokine response in neonates receiving a rbc transfusion

Conditions: Transfusions

Summary: prior to a non-urgent blood transfusion, subjects will be randomized to either stopping feeds or continuing feeds. the intervention group will be the placement of a subject in the npo group. subjects in the intervention group will have their feedings stopped for a total of 24 hours around the time of the prbc transfusion. these infants will be given intravenous nutrition during the period of time that they will not be fed. during the transfusion, both groups of subjects will have serum cytokine levels obtained at 3 time intervals- 1) 4 hours pre-transfusion, 2) 2-4 hours post-transfusion, and 3) 20-24 hours post-transfusion.

recently many publications have indicated a potential temporal association between packed red blood cell (prbc) transfusion and the development of nec in neonates. although, to date, there is no conclusive evidence indicating a causal role of prbc transfusion on the development of nec. given the growing body of data that support the association of prbc transfusions and nec, a common clinical dilemma arises with regard to feeding infants during a blood transfusion. additionally, it is thought that increased immunomodulation may be exacerbated by any other pro-inflammatory process or insult; thereby leading to a rapidly increasing cascade of pro-inflammatory cytokines which may ultimately lead to gut inflammation and nec. prior to a non-urgent prbc transfusion, subjects will be randomized to either the npo group or fed group of patients. the intervention will be the placement of a subject in the npo group. subjects will be made npo for a total of 24 hours around the time of the prbc transfusion. during the transfusion, both groups of subjects will have serum cytokine levels obtained at 3 time intervals- 1) 4 hours pre-transfusion, 2) 2-4 hours post-transfusion, and 3) 20-24 hours post-transfusion.

Eligibility criteria:
inclusion criteria: * infants born \< 31 weeks gestational age * between 3 and 7 days old at time of consent exclusion criteria: * infants with multiple congenital anomalies * infant with suspected/confirmed genetic anomalies * infant with suspected/confirmed congenital immune deficiencies

Keywords: pro inflammatory cytokine necrotizing enterocolitis packed red blood cell transfusion
study evaluating the safety, tolerability and brain function of 2 doses of pf-0254920 in subjects with early huntington's disease

Conditions: Huntington's Disease

Summary: this study will evaluate the safety, tolerability and brain function of 2 doses of pf-0254920 in subjects with early huntington's disease.


Eligibility criteria:
inclusion criteria: * must have a diagnosis of huntington's disease * a cag repeat expansion equal or great than 39 * a unified huntington disease rating scale (uhdrs) total motor score equal or greater than 5 and less than 60 * a uhdrs total functional capacity equal or greater than 9 exclusion criteria: * subjects with evidence or history of severe acute or chronic medical condition or laboratory abnormality, or significant neurological disorder other than hd. * treatment with any antipsychotic medication within 5 weeks of enrollment